AccessGUDID - DEVICE: Henry Schein® Pressure Indicator Paste (D6871721101FG2)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein® Pressure Indicator Paste
Version or Model: 1721101FG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1721101FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6871721101FG2
Issuing Agency: HIBCC
Commercial Distribution End Date: June 04, 2024
Device Count: 100
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Henry Schein® Pressure Indicator Paste - 2 oz

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61482	Dental cement trial	A non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFH	PAPER, ARTICULATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 Bottles (2 oz each)
Total Volume: 2 Fluid Ounce

Device Record Status

Public Device Record Key: 48b5ddb2-d479-45f7-9dfb-9c0a09cf6df8
Public Version Date: June 05, 2024
Public Version Number: 4
DI Record Publish Date: September 21, 2016